This week's sponsor is McKesson Life Sciences. | | | Today's Rundown FDA staff return to work, but threat of second shutdown looms EMA staff lower flags at London office as Amsterdam move nears Ex-Sanofi executive to head up translational medicine at LEO Pharma Alexion’s Soliris follow-up clears trial in aHUS, its second rare disease Preventing flu with an antibody-plus-Tamiflu universal vaccine Medtronic to buy EPIX and its RF-based cardiac ablation platform Featured Story | Monday, January 28, 2019 FDA staff are returning to paid work today after the longest government shutdown in U.S. history. But with temporary funding set to lapse Feb. 15 and President Donald Trump skeptical a deal can be reached, the agency may be plunged back into a shutdown in less than three weeks. |
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| Top Stories Monday, January 28, 2019 Staff at the European Medicines Agency have lowered the flags outside their London offices as they prepare to move to Amsterdam. The flag lowering took place as the EMA “symbolically said goodbye” to the city it has called home since its creation in 1995. Monday, January 28, 2019 LEO Pharma has hired Thomas Hultsch as its new head of translational medicine. Hultsch will build LEO Pharma’s presence in the U.S. and Europe, which includes overseeing the creation of a new translational medicine unit in Boston. Monday, January 28, 2019 Smarting from a patent defeat for cash cow Soliris in Europe, Alexion has dulled the pain with a phase 3 readout that sets up new filings for follow-up Ultomiris. Monday, January 28, 2019 The flu virus' ability to rapidly mutate into vaccine-resistant strains has made the search for a universal vaccine all the more challenging. Researchers from the National Institutes of Health have found a new clue to providing broad-based protection against the flu—and it rests partly on Roche’s FDA-approved remedy Tamiflu. Monday, January 28, 2019 Medtronic has moved to acquire EPIX Therapeutics and its catheter-based cardiac ablation system with plans to offer it alongside its own products and build out what the company describes as a “comprehensive suite of tools” for treating heart arrhythmias, including atrial fibrillation. This week's sponsor is ExL Events. | | | Enrollment Showcase | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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| Resources Sponsored by: Veradigm Clinical trials take too long and cost too much—here's what needs to change. Sponsored by: AlphaSense It’s never been more challenging to stay on top of competitive factors impacting your industry. Discover how AI can help competitive teams achieve more proactive market intelligence. Sponsored by: Reprints Desk, Inc. Go from Search to Full-Text Scientific Papers in a Single Click! Sponsored by: Blue Latitude Health This white paper consists of original data and expert interviews. Download it today for exclusive tools, tips and analysis on achieving launch excellence in challenging pharma markets. Sponsored by: Outer Edge Technology With FDA approval imminent, start-up Life Sciences company partners with an industry focused MSP to design and manage its regulated cloud-based infrastructure to speed time to market. Sponsored by: DeciBio Consulting With the liquid biopsy market maturing and >80 companies still competing with liquid biopsy offerings, it is crucial for investors to be able to cut through the noise and identify the winners. Presented by: Veeva Share your thoughts on the life sciences industry's progress in improving study execution. Presented by: Aprecia Get ahead of looming challenges in the market that include both generic products and new branded drugs. Sponsored by: Oracle Health Sciences New infographic shows trends in clinical development and the impact on randomization and trial supply management technology (RTSM). Sponsored by: Veeva Reduce the effort to create submissions and track registrations with a move to unified RIM. Watch the on-demand webinar. Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. 2nd Innovative Regulatory Pathways Summit January 28, 2019, 8 AM - January 29, 2019, 2:45 PM | Sheraton Pentagon City Hotel, Arlington, VA BIO CEO & Investor Conference February 11-12, 2019 | New York Marriott Marquis 2019 Bridging Clinical Research & Clinical Health Care Collaborative March 4–5, 2019 | National Academy of Sciences | Washington, D.C. Asia-Pacific Compliance Training for Life Sciences Professionals March 4-7, 2019 | Singapore BIO Asia International Conference March 5-6, 2019 | Grand Hyatt Tokyo | Tokyo, Japan Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! |